- This presentation will provide a case study of a HF program for the development of a combination product used to treat type II diabetes
- This product was initiated in 2009 and has therefore been developed during a period of evolving HF guidance. The presentation will discuss evaluations that were conducted at multiple design stages with representative users, as well as iterations to the design user interface to mitigate observed performance issues
- This presentation will include an overview of interactions with regulators as well as the importance of having a dialogue with regulators throughout the development process.
James Meehan, Associate Principal Scientist – Human Factors , AstraZeneca